Nutrition plays a critical role in maintaining good health. Proper nutrition prevents dietary deficiencies, and also protects against the development of disease. When the body faces physiological stress, proper nutrition plays an increasingly important role. For example, pregnancy and lactation are among the most nutritionally volatile and physiologically stressful periods and processes in the lifetimes of women. Vitamin and mineral needs are almost universally increased during these natural processes. Increased vitamin and mineral needs during these times are almost always due to elevated metabolic demand, increased plasma volume, increased levels of blood cells, decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins.
When increased nutrient needs occur during pregnancy, lactation, or any other physiologically stressful state, nutritional supplementation serves a vital role in maintaining good health. Nutritional supplementation is especially pertinent to women contemplating conceiving a child because optimizing specific nutrients before, during, and after the physiological processes of pregnancy or lactation can have profound, positive, and comprehensive impacts upon the overall wellness of the developing and newborn child as well as on the safety and health of the mother. The present invention provides compositions, kits and methods designed to supplement the nutritional needs of individuals in physiologically stressful states.
Supplementation with certain vitamins and minerals serves a role in protecting against disease and contributes to the overall health of the mother and developing child. Specifically, vitamins, nutrients and minerals such as vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, and omega 3 fatty acids such as docosahexaenoic acid (DHA), play integral roles in physiological mechanisms that serve to prevent, treat and/or alleviate the occurrence or negative effects of some diseases.
Iodine also provides nutritional benefits as it is an essential component of the thyroid hormones that are involved in the regulation of various enzymes and metabolic processes, such as thyroxine and triiodothyronine. Indeed, iodine deficiency disorders (IDD) include mental retardation, hypothyroidism, goiter, cretinism, and varying degrees of other growth and developmental abnormalities which can be a result from inadequate thyroid hormone production from lack of sufficient iodine. See, for example, Food and Nutrition Board and Institute of Medicine, DIETARY REFERENCE INTAKES FOR VITAMIN A, VITAMIN K, ARSENIC, BORON, CHROMIUM, COPPER, IODINE, IRON, MANGANESE, MOLYBDENUM, NICKEL, SILICON, VANADIUM, AND ZINC (2001), page 260. Further, iodine is an important element in breast milk for infant nutrition. An adequate concentration of iodine in breast milk is essential to provide for optimal neonatal thyroid hormone stores and to prevent impaired neurological development in breast-fed neonates. In many countries of the world, low iodine content of the breast milk indicates less than optimum maternal and infant iodine nutrition. F. Azizi et al., CLIN ENDOCRINOL, 70 (5):803-9 (2009). Multivitamin and multi nutritional supplements, for example for prenatal pregnant or breast-feeding women, are also lacking or deficient in the dosage amount of this important mineral.
In another example, there is a need for a nutritional supplement with increased vitamin D, in for example, a prenatal or dietary supplement, as recent research suggests that vitamin D has more positive physiological effects than previous thought, in for example prenatal and pregnant women. It has recently been determined that vitamin D has previously unknown roles in the enhancement of vascular function, defense against cancer, immuno-competence, blood pressure regulation and possessing the ability to enhance cellular insulin sensitivity in the human body. Due to the additional roles that vitamin D plays in the human body, it has recently been determined that higher daily vitamin D intake beyond current recommendations may be associated with better health outcomes. Indeed, studies suggest increasing the serum level of 25-hydroxyvitamin D, a beneficial derivative of vitamin D, to a 30 ng/ml serum range. A 30 ng/ml appears to be the most advantageous serum level in recent studies reviewing patient bone mineral density (BMD), lower extremity function, dental health, risk of falls, admission to nursing home, fractures, cancer prevention and incident hypertension. Bischoff-Ferrari H A, ADV EXP MED BIOL. 624:55-71 (2008). Effective and safe doses of vitamin D to bring serum levels of 25-hydroxyvitamin D up to a desirable level of 30 ng/ml is currently needed.
Lastly, a present problem with nutritional supplements that include multiple vitamins, nutrients and minerals is the ability to include all the components in one composition. Providing a single composition multivitamin and multinutrient supplement is an appealing feature because it improves patient compliance. Patients, and specifically for example, pregnant patients, often have nausea, and may have difficulty swallowing nutritional supplements. Compliance issues regarding taking multiple pills may therefore result. A one pill or one composition nutritional supplement that includes the beneficial vitamins, nutrients and minerals in appropriate dosage amounts would thus be beneficial for improving patient compliance in for example, pregnant women. A difficulty in the nutrition supplement market, however, is the ability to include multiple vitamins, minerals and nutrients of various water or fat solubilities in the needed dosage amounts all in one composition. For example, nutritional supplements that include fat soluble compounds such as DHA and water soluble vitamins such as B-complex vitamins and vitamin C, are often separated into multiple compositions. A supplement comprising multiple vitamins, nutrients and minerals blended to form a single composition, is thus currently needed. In a specific example, the single composition may be in the form of a gelcap. Patient compliance is also improved if a gelcap is used to administer the drug because of its soft and elastic nature, which makes it easier to swallow compared to a hard tablet or caplet.
A liquid gelcap also has numerous advantages. First, it retains many of the advantages of consumer acceptance and is easier to swallow due to the outer coating being a soft and elastic gelatin shell. Also, concentrated liquid compositions are well suited for encapsulation within a soft gelatin shell, creating flexibility that further assists in the capsule being easier to swallow. The active drug contained in the liquid form also provides advantages by dispersing the drug to the active site. For example, the active drug does not first have to dissolve in the gastrointestinal tract, thereby facilitating absorption of the pharmacologically active substance. See, for example, U.S. Pat. No. 6,689,382, which is expressly incorporated by reference herein. Other formulations take advantage of the liquid form by creating a sustained release gelatin capsule, thereby permitting the delivery of the drug in a controlled fashion. See, for example, U.S. Pat. Nos. 5,324,280 and 6,929,803, which are expressly incorporated by reference herein.